Job Description Job Overview: In this role the Senior Director, Facilities & Engineering will be responsible for the Engineering, Maintenance, and Site Services for the Pharmaceutics International Inc., ('Pii'), Holly Mount, MD Facilities, which includes the four buildings owned or leased by Pii (collectively 'the Site'). The Senior Director, Facilities & Engineering provides life cycle asset and facilities management leadership for the Site by implementing strategies that assure sustainable, reliable and repeatable performance for compliant, effective and efficient infrastructure. Under the general supervision of the Site General Manager, the incumbent is responsible for all activities related to Site Engineering, Capital, EH&S and Facilities Reliability Operations. The span of control of this position includes all plant infrastructure, facilities reliability, automation, and utilities programs; as well as all aspects of engineering with a special focus on GMP Manufacturing equipment uptime, including the routine reporting of equipment and system status, and the reliable supply and compliance of Critical Utilities (HVAC, Purified Water, Clean Compressed Air, etc.) as well as utility (plant water, electrical service and wastewater) and indirect utilities (chilled water, cooling, tower, chillers, compressed air systems, etc.) In addition, the incumbent is responsible for project scoping, capital and department expense budgeting and monthly forecasting, governance, day-to-day management of site capital projects and escalation of critical issues related to safety and/or operations impacts. The Site Engineering Manager is also accountable for commissioning and qualification activities associated with capital projects. The Senior Director, Facilities & Engineering will maintain a learning organization, establish training curriculums and enforce training requirements and timelines, develop engineering department leaders and promote collaboration with internal key stakeholders (including manufacturing, technology, supply chain, finance, etc.), and establish and maintain routine governance processes to maintain proactive lines of communications. The Senior Director, Facilities & Engineering is a member of the Site Leadership Team ('SLT') and is expected to routinely report out on the state of good repair both to the SLT and as required to support Quality Assurance Programs (Quality Managements Reviews, Deviation, CAPA and Continuous Improvement, etc.). Responsibilities: Maintain a safe working environment. Monitor and report on department (and Site?) Environmental, Health and Safety Performance. Support and comply with required safety training and required safety system testing for equipment and facilities Support the design, construction, and operation of all four (4) facilities such as solid, soft gel, Aseptic manufacturing, and GMP labels. Ensure the Pii facilities meets the appropriate cGMP standard or identify where the gaps are in the Pii Facilities GMP compliance position and make recommendations to the leadership team for the remediation of the gap. Supervise, and monitor the environmental conditions of the cGMP areas, and ensure all parameters meet the cGMP requirements. Manage and maintain the annual site capital expenditure (cap EX). Develop an annual Facilities and Engineering department operating expense budget and routinely forecast performance to the budget. Proactively collaborate with Finance regarding capital or operating budget status. Responsible for ensuring that the facility and equipment are kept up-to-date and in a good state of repair. Maintain an asset management plan and a Computerized Maintenance Management System. Develop and implement the automation vision and strategy for the organization Develop cost effective and accelerated initiatives to meet high mix/low volume applications Drive technical automation teams in the development of innovative automation equipment and solution design(s) Optimize automation equipment, improve production efficiency, including where necessary reforming the existing automation technology. Provide engineering and reliability support for all agency audits like FDA, MHRA, and EMA. Maintain all facility drawings of record, facility design strategies, and on-going controlled environment data. Reviewing SOP, URS, DQ, TQ, IQ, OQ, PQ's and Change Controls for all facility engineering equipment and controlled and non-controlled Site environments. Facilitate and lead facilities engineering capital projects related to new and upgraded equipment, processes, facilities, IT site operational initiative, site compliance, quality and safety initiatives. Support and Lead all facility/equipment/systems related Change Controls, Quality Events (QE), Deviations, Corrective and Preventative Action (CAPA's), Continuous Improvements and Effectiveness Checks. Implement and enforce engineering and reliability procurement processes and standards for securing services, equipment, and materials. Reviews proposals, negotiates prices, selects, and recommends suppliers, analyze cost trends, follows up on orders placed, verifies deliveries, approves vendor payments and maintains necessary records. Communicate cross-functionality with customers, vendors, suppliers, contractors, and management on all department needs and project-related activities. Manage, track, and ensure that all GMP work orders are performed as required. Review all the clean room parameters such as pressure, temperature, and humidity. Maintain and regulate/control the HVAC and SCADA Hire required personnel for the department, and provide the necessary training. Perform other duties as assigned. Qualifications: Bachelor's degree in Mechanical Engineering, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities. Maryland first-grade stationary engineer license 8 to 10 years of work experience in the pharmaceutical industry Extensive technical acumen in the field of automation including automation design and implementation Demonstrated track record leading multiple successful automation implementations Building and equipment maintenance work experience Knowledgeable in AutoCAD and building management system (BMS) Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates. Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision. Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required. Must be able to comprehend and follow all applicable SOPs. Demonstrate ability to acquire knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise. Demonstrate ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products. Good understanding of cGMPs, Good Engineering Practice ('GEP'), Lean and Six-sigma, industry, and regulatory standards and guidelines. Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc. Demonstrate the ability to portray the appropriate level of integrity and professionalism. Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats. Demonstrate the ability to complete tasks accurately and according to established and shifting timelines. Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions. Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment. Results-oriented and efficient. Creative and open-minded who fosters an environment in which sharing of ideas is encouraged. Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally). Demonstrate the ability to work well in a cross-functional team environment. Must communicate fluently in English and have legible handwriting. Physical Demands: Ability to travel between and within facilities to visit staff, operations, and projects, as needed. Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary). Ability to lift up to 40 pounds on occasion. Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
12/17/2025
Full time
Job Description Job Overview: In this role the Senior Director, Facilities & Engineering will be responsible for the Engineering, Maintenance, and Site Services for the Pharmaceutics International Inc., ('Pii'), Holly Mount, MD Facilities, which includes the four buildings owned or leased by Pii (collectively 'the Site'). The Senior Director, Facilities & Engineering provides life cycle asset and facilities management leadership for the Site by implementing strategies that assure sustainable, reliable and repeatable performance for compliant, effective and efficient infrastructure. Under the general supervision of the Site General Manager, the incumbent is responsible for all activities related to Site Engineering, Capital, EH&S and Facilities Reliability Operations. The span of control of this position includes all plant infrastructure, facilities reliability, automation, and utilities programs; as well as all aspects of engineering with a special focus on GMP Manufacturing equipment uptime, including the routine reporting of equipment and system status, and the reliable supply and compliance of Critical Utilities (HVAC, Purified Water, Clean Compressed Air, etc.) as well as utility (plant water, electrical service and wastewater) and indirect utilities (chilled water, cooling, tower, chillers, compressed air systems, etc.) In addition, the incumbent is responsible for project scoping, capital and department expense budgeting and monthly forecasting, governance, day-to-day management of site capital projects and escalation of critical issues related to safety and/or operations impacts. The Site Engineering Manager is also accountable for commissioning and qualification activities associated with capital projects. The Senior Director, Facilities & Engineering will maintain a learning organization, establish training curriculums and enforce training requirements and timelines, develop engineering department leaders and promote collaboration with internal key stakeholders (including manufacturing, technology, supply chain, finance, etc.), and establish and maintain routine governance processes to maintain proactive lines of communications. The Senior Director, Facilities & Engineering is a member of the Site Leadership Team ('SLT') and is expected to routinely report out on the state of good repair both to the SLT and as required to support Quality Assurance Programs (Quality Managements Reviews, Deviation, CAPA and Continuous Improvement, etc.). Responsibilities: Maintain a safe working environment. Monitor and report on department (and Site?) Environmental, Health and Safety Performance. Support and comply with required safety training and required safety system testing for equipment and facilities Support the design, construction, and operation of all four (4) facilities such as solid, soft gel, Aseptic manufacturing, and GMP labels. Ensure the Pii facilities meets the appropriate cGMP standard or identify where the gaps are in the Pii Facilities GMP compliance position and make recommendations to the leadership team for the remediation of the gap. Supervise, and monitor the environmental conditions of the cGMP areas, and ensure all parameters meet the cGMP requirements. Manage and maintain the annual site capital expenditure (cap EX). Develop an annual Facilities and Engineering department operating expense budget and routinely forecast performance to the budget. Proactively collaborate with Finance regarding capital or operating budget status. Responsible for ensuring that the facility and equipment are kept up-to-date and in a good state of repair. Maintain an asset management plan and a Computerized Maintenance Management System. Develop and implement the automation vision and strategy for the organization Develop cost effective and accelerated initiatives to meet high mix/low volume applications Drive technical automation teams in the development of innovative automation equipment and solution design(s) Optimize automation equipment, improve production efficiency, including where necessary reforming the existing automation technology. Provide engineering and reliability support for all agency audits like FDA, MHRA, and EMA. Maintain all facility drawings of record, facility design strategies, and on-going controlled environment data. Reviewing SOP, URS, DQ, TQ, IQ, OQ, PQ's and Change Controls for all facility engineering equipment and controlled and non-controlled Site environments. Facilitate and lead facilities engineering capital projects related to new and upgraded equipment, processes, facilities, IT site operational initiative, site compliance, quality and safety initiatives. Support and Lead all facility/equipment/systems related Change Controls, Quality Events (QE), Deviations, Corrective and Preventative Action (CAPA's), Continuous Improvements and Effectiveness Checks. Implement and enforce engineering and reliability procurement processes and standards for securing services, equipment, and materials. Reviews proposals, negotiates prices, selects, and recommends suppliers, analyze cost trends, follows up on orders placed, verifies deliveries, approves vendor payments and maintains necessary records. Communicate cross-functionality with customers, vendors, suppliers, contractors, and management on all department needs and project-related activities. Manage, track, and ensure that all GMP work orders are performed as required. Review all the clean room parameters such as pressure, temperature, and humidity. Maintain and regulate/control the HVAC and SCADA Hire required personnel for the department, and provide the necessary training. Perform other duties as assigned. Qualifications: Bachelor's degree in Mechanical Engineering, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities. Maryland first-grade stationary engineer license 8 to 10 years of work experience in the pharmaceutical industry Extensive technical acumen in the field of automation including automation design and implementation Demonstrated track record leading multiple successful automation implementations Building and equipment maintenance work experience Knowledgeable in AutoCAD and building management system (BMS) Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates. Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision. Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required. Must be able to comprehend and follow all applicable SOPs. Demonstrate ability to acquire knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise. Demonstrate ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products. Good understanding of cGMPs, Good Engineering Practice ('GEP'), Lean and Six-sigma, industry, and regulatory standards and guidelines. Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc. Demonstrate the ability to portray the appropriate level of integrity and professionalism. Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats. Demonstrate the ability to complete tasks accurately and according to established and shifting timelines. Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions. Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment. Results-oriented and efficient. Creative and open-minded who fosters an environment in which sharing of ideas is encouraged. Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally). Demonstrate the ability to work well in a cross-functional team environment. Must communicate fluently in English and have legible handwriting. Physical Demands: Ability to travel between and within facilities to visit staff, operations, and projects, as needed. Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary). Ability to lift up to 40 pounds on occasion. Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
Jabil is expanding! We have an exciting opportunity for an Environmental Health and Safety (EHS) Manager to drive EHS operations for our new state-of -the-art site in Salisbury, NC (near Charlotte)! This is a great opportunity to become of apart of the exciting industry of data center infrastructure manufacturing. This is a site level role where you will play an integral part of the build out of the facility as well the development of EHS programs from the ground up! Relocation available! This role may require extensive travel to other Jabil sites during the first 3-6 months for training, team integration, and operational alignment. How will you make an impact? As a Environmental Health and Safety (EHS) Manager, you will be responsible for establishing health and safety policies and procedures which ensure compliance with company, customer, and government regulations within any of the following functions: health and safety, industrial hygiene, or environmental protection. What will you do? Recruitment and Retention Recruit, interview and hire for the Environmental, Health, and Safety team. Communicate criteria to recruiters for the Environmental, Health, and Safety team. Monitor team member turnover; identify key factors that can be improved; make improvements. Employee and Team Development Identify individual and team strengths and development needs on an ongoing basis. Create and/or validate training curriculum in area of responsibility (Environmental Management Programs, Safety & Health Programs, Emergency plans, Business Continuity Plan). Coach and mentor EHS team members to deliver excellence to every internal and external customer. Create and manage succession plans for EHS function. Performance Management Establish clear measurable goals and objectives by which to determine individual and team results ( i.e. results against project timelines, training documentation, attendance records, knowledge of operational roles and responsibilities, personal development goals). Solicit ongoing feedback from Manufacturing Managers, peers and team member on team member's contribution to the team. Provide coaching and counseling to team member based on feedback. Express pride in staff and encourage them to feel good about their accomplishments. Perform team member evaluations professionally and on time. Drive individuals and the team to continuously improve in departmental goals. Coordinate activities of large teams and keep them focused in times of crises. Ensure recognition and rewards are managed fairly and consistently in area of responsibility. Communication Provide communication forum for the exchange of ideas and information with the department. Organize verbal and written ideas clearly and succinctly using an appropriate business style. Ask questions; encourage input from team members. Assess communication style of individual team members and adapt own communication style accordingly. Influence organization to practice proper EHS procedures using marketing strategies and easy to use tools. Business Strategy and Direction Know and understand the campus strategic direction. Define, develop and implement an Environmental, Health & Safety strategy that contributes to the campus strategic directions . Develop an understanding of the Workcell business strategy as it pertains to EHS. Provide regular updates to Facilities Manager and Operations Manager on the execution of the strategy. Cost Management Identify creative ways to reduce cost by streamlining processes and systems ( i.e. modification of responsibilities or consolidation of tasks, elimination of non-value-added processes, or complete re-engineering of processes and systems). Utilize tools to monitor departmental cost and cost trends, striving continuously to improve value ( i.e. cost of Workers Compensation versus cost of wearing Safety glasses). Provide feedback to management on cost and cost trends. Forecast Development and Accuracy Provide feedback to Facilities Manager and Operations Manager on forecasts for the department. Technical Management Responsibilities Drive continuous improvement through trend reporting analysis and metrics management. Assess the adequacy of data gathering methods utilized by the workcells . Assure that procedures and work instructions are efficient and not redundant. Offer new ideas and suggestions for improvement. Identify and implement new practices and processes that are "best in field." Implement the Environmental, Health, And Safety (EHS) activities in support of ISO 14000. Determine how to influence activities (facilities, building support, EHS, and security) under a single focus to streamline execution. Demonstrate a commitment to customer service; anticipate , meet, and exceed expectations by solving problems quickly and effectively; making customer issues a priority. Establish new measurement systems if/where possible. Exchange knowledge and information with other Jabil facilities to ensure best practices are shared throughout the Jabil organization. Ensure all sensitive and confidential information is handled appropriately. Stay up to date on environmental issues. Chair the Safety Committee. Manage large projects from start to finish utilizing delegating skills to empower others to take responsibility for segments of the project. Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor. Comply and follow all procedures within the company security policy. May perform other duties and responsibilities as assigned. How will you get here? Education Bachelor's degree in Environmental , Health and Safety or equivalent preferred Experience 5 years of EHS experience in a manager level position Manufacturing industry experience preferably electronics manufacturing New site, startup, and/or construction related EHS experience highly desired Knowledge, Skills, Abilities Expert knowledge of ISO 14001 and 45001 S tandard and system requirements. Kno wledge and experience of National Fire Protection Association (NFPA) requirements, specifically NFPA 70E. Expert Knowledge and experience with implementation and compliance assurance with Occupational Health and Safety Administration (OSHA) requirements , specifically OSHA 1910 . Knowledge and experience interpreting and implementing health and safety programs; including, but not limited to: ergonomics, emergency response and incident management, and risk assessments and job hazard assessments . Experience im plementing management of change, continuous improvement, and organizational leadership concepts. Knowledge and experience interpreting and implementing Environmental Protection Agency (EPA), and/or state and local equivalents to evalu ate the n eed for and ensure compliance with regulatory environmental permits. Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Strong knowledge of global and regional logistics operations and industry. Strong proficiency in determining logistics requirements to enable company's business goals and objectives with ability to devise and implement strategy to achieve targets. Strong financial and analytical ability. Proficiency in managing business analytics to determine optimum company footprint. Strong knowledge of international direct and indirect taxes as well as global customs regimes. Proven track record of successful change management accomplishments, implementing and management continuous productivity and cost reduction programs. Strong and convincing communication skills . Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required . What can Jabil offer you? Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes: Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options 401K Match . click apply for full job details
12/16/2025
Full time
Jabil is expanding! We have an exciting opportunity for an Environmental Health and Safety (EHS) Manager to drive EHS operations for our new state-of -the-art site in Salisbury, NC (near Charlotte)! This is a great opportunity to become of apart of the exciting industry of data center infrastructure manufacturing. This is a site level role where you will play an integral part of the build out of the facility as well the development of EHS programs from the ground up! Relocation available! This role may require extensive travel to other Jabil sites during the first 3-6 months for training, team integration, and operational alignment. How will you make an impact? As a Environmental Health and Safety (EHS) Manager, you will be responsible for establishing health and safety policies and procedures which ensure compliance with company, customer, and government regulations within any of the following functions: health and safety, industrial hygiene, or environmental protection. What will you do? Recruitment and Retention Recruit, interview and hire for the Environmental, Health, and Safety team. Communicate criteria to recruiters for the Environmental, Health, and Safety team. Monitor team member turnover; identify key factors that can be improved; make improvements. Employee and Team Development Identify individual and team strengths and development needs on an ongoing basis. Create and/or validate training curriculum in area of responsibility (Environmental Management Programs, Safety & Health Programs, Emergency plans, Business Continuity Plan). Coach and mentor EHS team members to deliver excellence to every internal and external customer. Create and manage succession plans for EHS function. Performance Management Establish clear measurable goals and objectives by which to determine individual and team results ( i.e. results against project timelines, training documentation, attendance records, knowledge of operational roles and responsibilities, personal development goals). Solicit ongoing feedback from Manufacturing Managers, peers and team member on team member's contribution to the team. Provide coaching and counseling to team member based on feedback. Express pride in staff and encourage them to feel good about their accomplishments. Perform team member evaluations professionally and on time. Drive individuals and the team to continuously improve in departmental goals. Coordinate activities of large teams and keep them focused in times of crises. Ensure recognition and rewards are managed fairly and consistently in area of responsibility. Communication Provide communication forum for the exchange of ideas and information with the department. Organize verbal and written ideas clearly and succinctly using an appropriate business style. Ask questions; encourage input from team members. Assess communication style of individual team members and adapt own communication style accordingly. Influence organization to practice proper EHS procedures using marketing strategies and easy to use tools. Business Strategy and Direction Know and understand the campus strategic direction. Define, develop and implement an Environmental, Health & Safety strategy that contributes to the campus strategic directions . Develop an understanding of the Workcell business strategy as it pertains to EHS. Provide regular updates to Facilities Manager and Operations Manager on the execution of the strategy. Cost Management Identify creative ways to reduce cost by streamlining processes and systems ( i.e. modification of responsibilities or consolidation of tasks, elimination of non-value-added processes, or complete re-engineering of processes and systems). Utilize tools to monitor departmental cost and cost trends, striving continuously to improve value ( i.e. cost of Workers Compensation versus cost of wearing Safety glasses). Provide feedback to management on cost and cost trends. Forecast Development and Accuracy Provide feedback to Facilities Manager and Operations Manager on forecasts for the department. Technical Management Responsibilities Drive continuous improvement through trend reporting analysis and metrics management. Assess the adequacy of data gathering methods utilized by the workcells . Assure that procedures and work instructions are efficient and not redundant. Offer new ideas and suggestions for improvement. Identify and implement new practices and processes that are "best in field." Implement the Environmental, Health, And Safety (EHS) activities in support of ISO 14000. Determine how to influence activities (facilities, building support, EHS, and security) under a single focus to streamline execution. Demonstrate a commitment to customer service; anticipate , meet, and exceed expectations by solving problems quickly and effectively; making customer issues a priority. Establish new measurement systems if/where possible. Exchange knowledge and information with other Jabil facilities to ensure best practices are shared throughout the Jabil organization. Ensure all sensitive and confidential information is handled appropriately. Stay up to date on environmental issues. Chair the Safety Committee. Manage large projects from start to finish utilizing delegating skills to empower others to take responsibility for segments of the project. Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor. Comply and follow all procedures within the company security policy. May perform other duties and responsibilities as assigned. How will you get here? Education Bachelor's degree in Environmental , Health and Safety or equivalent preferred Experience 5 years of EHS experience in a manager level position Manufacturing industry experience preferably electronics manufacturing New site, startup, and/or construction related EHS experience highly desired Knowledge, Skills, Abilities Expert knowledge of ISO 14001 and 45001 S tandard and system requirements. Kno wledge and experience of National Fire Protection Association (NFPA) requirements, specifically NFPA 70E. Expert Knowledge and experience with implementation and compliance assurance with Occupational Health and Safety Administration (OSHA) requirements , specifically OSHA 1910 . Knowledge and experience interpreting and implementing health and safety programs; including, but not limited to: ergonomics, emergency response and incident management, and risk assessments and job hazard assessments . Experience im plementing management of change, continuous improvement, and organizational leadership concepts. Knowledge and experience interpreting and implementing Environmental Protection Agency (EPA), and/or state and local equivalents to evalu ate the n eed for and ensure compliance with regulatory environmental permits. Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Strong knowledge of global and regional logistics operations and industry. Strong proficiency in determining logistics requirements to enable company's business goals and objectives with ability to devise and implement strategy to achieve targets. Strong financial and analytical ability. Proficiency in managing business analytics to determine optimum company footprint. Strong knowledge of international direct and indirect taxes as well as global customs regimes. Proven track record of successful change management accomplishments, implementing and management continuous productivity and cost reduction programs. Strong and convincing communication skills . Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required . What can Jabil offer you? Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes: Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options 401K Match . click apply for full job details
JOB SUMMARY Working under general supervision, plans, maps, sequences and performs assembly of complex electrical, mechanical and pneumatic robotic and equipment from verbal and written instructions. Performs layout of mechanical, pneumatic and electrical schematics. ESSENTIAL DUTIES AND RESPONSIBILITIES Performs a variety of diagnostic troubleshooting activities on assembly automation equipment. Makes mechanical, electrical, pneumatic or hydraulic repairs to assembly automation equipment Performs equipment failure analysis, repairs, and scheduled preventative maintenance on robotic and automated equipment. Sets up manual and semi-automatic assembly lines and assists in operating pre-production runs. Assists in installing new automated equipment and in moving equipment to new locations. Creates new robot programs and edit existing robot programs. Updates manuals and programs for automated equipment. Keeps accurate reports of all activities performed on each piece of equipment. Provides input to engineering staff on areas for machine improvements. Sets up and maintains production maintenance schedule and parts inventory. Ensures all software is backed up and up-to-date. Works with Maintenance and Process Technicians to maintain daily production operations and assembly through preventative and corrective maintenance. Supports all company safety and quality programs and initiatives. Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position. May perform other duties and responsibilities as assigned. JOB QUALIFICATIONS KNOWLEDGE REQUIREMENTS Ability to use advanced trades mathematics together with use of complex drawings, specifications and charts. Ability to use all varieties of precision measuring instruments Must be able to apply judgment to perform more difficult work with use of complex drawings, specifications and charts. Ability to program and troubleshoot PLC (programmable logic controllers) and ladder logic. Ability to read and understand electrical drawings and schematics.
12/15/2025
Full time
JOB SUMMARY Working under general supervision, plans, maps, sequences and performs assembly of complex electrical, mechanical and pneumatic robotic and equipment from verbal and written instructions. Performs layout of mechanical, pneumatic and electrical schematics. ESSENTIAL DUTIES AND RESPONSIBILITIES Performs a variety of diagnostic troubleshooting activities on assembly automation equipment. Makes mechanical, electrical, pneumatic or hydraulic repairs to assembly automation equipment Performs equipment failure analysis, repairs, and scheduled preventative maintenance on robotic and automated equipment. Sets up manual and semi-automatic assembly lines and assists in operating pre-production runs. Assists in installing new automated equipment and in moving equipment to new locations. Creates new robot programs and edit existing robot programs. Updates manuals and programs for automated equipment. Keeps accurate reports of all activities performed on each piece of equipment. Provides input to engineering staff on areas for machine improvements. Sets up and maintains production maintenance schedule and parts inventory. Ensures all software is backed up and up-to-date. Works with Maintenance and Process Technicians to maintain daily production operations and assembly through preventative and corrective maintenance. Supports all company safety and quality programs and initiatives. Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position. May perform other duties and responsibilities as assigned. JOB QUALIFICATIONS KNOWLEDGE REQUIREMENTS Ability to use advanced trades mathematics together with use of complex drawings, specifications and charts. Ability to use all varieties of precision measuring instruments Must be able to apply judgment to perform more difficult work with use of complex drawings, specifications and charts. Ability to program and troubleshoot PLC (programmable logic controllers) and ladder logic. Ability to read and understand electrical drawings and schematics.
Job Summary: The Director of Validation will lead all validation activities across pharmaceutical and medical device manufacturing operations with a strong focus on sterile/aseptic manufacturing environments. The scope of responsibility encompasses all planning and implementation of drug and medical device overall validation activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process in compliance with global regulatory requirements (FDA, EMA, ICH, etc.)aseptic fill-finish environment and ensuring the proper validation of all equipment and processes. The Validation Director will also schedule the appropriate resources for assistance with validation, to meet the established production schedule, vendor/contract activities in the cleanrooms, maintain a state of control within the cleanroom environment, and support facilities and other operations, development, and maintenance of validation program documents including SOPs, Validation Project (VPP) and Validation Master (VMP) Plans. This individual should manage tasks and responsibilities with minimal guidance and demonstrate outstanding multi-tasking, problem-solving, and communication skills in a dynamic and challenging contract manufacturing environment. The role ensures a state of control is maintained across all systems and processes, supporting product quality, patient safety, and regulatory compliance This position requires strategic leadership, cross-functional collaboration, and technical expertise to drive validation excellence across multiple production areas and projects. Duties/Responsibilities: Lead the development, execution, and lifecycle management of validation programs (VMPs, VPPs, SOPs) for sterile and non-sterile operations. Responsible for directing and mentoring validation staff across multiple production areas to ensure the proper and continuous function of the operations team and adherence to the established procedures and schedulesin alignment with corporate quality and operational goals. Assess process validation capabilities within the Operations organization and propose strategies for improvements to help achieve both short-term and long-term corporate objectives. Direct personnel to the author, complete, and review all associated validation protocols (IQ, OQ, PQs). Write, review, and approve change control orders and CAPAs, validation deviations, investigations, Quality Management System (QMS) oversight, audit, inspection follow-up (CAPA), and support readiness activities for validation. Collaborate with senior validation leadership, outline validation strategy for new processes/equipment, and translate those required to appropriate validation protocols and standard operating procedures. Oversee, assign, and manage all aseptic validation activities and equipment (e.g., lyophilizers, isolators, autoclaves, filling lines), clean utilities (WFI, PW, HVAC), and critical systems Accountable for maintaining the Master Validation Plan of aseptic and non-aseptic processing. Provide strategic direction to process validation strategies, serve as the Subject Matter Expert (SME) to support inspections/audits by third parties (e.g., regulatory agencies), and the timely closure of observations/audit terms. Interface with Regulatory agencies, as required, in conjunction with facility inspections and technical interchanges to represent the company's position concerning validation. Mentor and develop staff regarding teamwork, validation techniques, and procedures to ensure cGMP compliance and other duties, as assigned or as business needs require. Provide direction and serve as project and resource management for the validation teams. Provide oversight and strategic direction for the Computer System Validation (CSV) program and supervise CSV associates. Ensure compliance with cGMP, FDA, EMA (Annex 1), and other global regulatory requirements for validation and qualification. Collaborate with Engineering, Quality Assurance, Manufacturing, and Client to ensure validation strategies support product lifecycle and regulatory submissions. Manage risk-based validation approaches and implement continuous improvement initiatives. Provide strategic input on new facility and equipment design to ensure validation readiness. Lead validation readiness for tech transfers, new product introductions, and capital projects. Ensure robust training and development programs for validation staff. Oversee the aseptic process simulation (APS) program to ensure compliance and readiness for regulatory inspections. Other assigned responsibilities, as needed. Required Skills/Abilities: Ability to read, write, and speak English fluently. Deep understanding of aseptic processing, cleanroom classifications, and contamination control principles. Demonstrated leadership in managing cross-functional teams and complex projects. Proficiency in validation lifecycle documentation and electronic systems (e.g., QMS, VMS, LIMS). Proficient in the operation of manufacturing equipment and processes; knows and complies with Safety Data Sheets and SOP requirements and trained in cGMP's. Mechanically inclined; reads and interprets equipment and process documents; follow operating instructions; and has good computer skills. Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality. Consistently checks all documents for errors and constantly strives for right the first-time mentality. Observes safety and security procedures; responsible for meeting department safety objectives and developing ongoing safe operating procedures consistent with the job requirements. Advanced understanding of applicable regulatory requirements (FDA, EMA, WHO, ICH, international regulatory). Audit experience is strongly preferred. Advanced understanding of industry standards for commissioning and validation of facilities, utilities, and process equipment for cGMP manufacturing. Demonstrate SME-level knowledge of process/equipment validation, computer systems, standards, and GxP regulations. Expertise in validation of sterile manufacturing equipment and processes. Strong technical experience in the successful management of complex validation is required. Able to effectively lead and coordinate complex requests/projects and allocate resources across multiple sites, managing local and remote-based staff. Strong oral and written (reports) communication, organization, and leadership skills. Education and Experience: Bachelor's degree in Science or Engineering, Master's degree preferred Minimum 15 years of progressive leadership of operational validation experience in the Pharmaceutical or Biotechnology industry, with at least 5 years in sterile/aseptic operations. Sound industry knowledge of pharmaceutical and medical device facilities, lyophilization technology, cleanrooms, facilities clean utilities. WFI, purified water, process gasses, HVAC, and industrial processes and utilities. Experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff. Proven track record of leading validation programs in a regulated environment. Experience with regulatory inspections and successful remediation of validation-related findings. Strong experience with project and people management, particularly for large validation projects or programs. Experience in Facility, Equipment, and Utility or Cleaning validation is a must. Experience with Process Validation as a plus.
12/15/2025
Full time
Job Summary: The Director of Validation will lead all validation activities across pharmaceutical and medical device manufacturing operations with a strong focus on sterile/aseptic manufacturing environments. The scope of responsibility encompasses all planning and implementation of drug and medical device overall validation activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process in compliance with global regulatory requirements (FDA, EMA, ICH, etc.)aseptic fill-finish environment and ensuring the proper validation of all equipment and processes. The Validation Director will also schedule the appropriate resources for assistance with validation, to meet the established production schedule, vendor/contract activities in the cleanrooms, maintain a state of control within the cleanroom environment, and support facilities and other operations, development, and maintenance of validation program documents including SOPs, Validation Project (VPP) and Validation Master (VMP) Plans. This individual should manage tasks and responsibilities with minimal guidance and demonstrate outstanding multi-tasking, problem-solving, and communication skills in a dynamic and challenging contract manufacturing environment. The role ensures a state of control is maintained across all systems and processes, supporting product quality, patient safety, and regulatory compliance This position requires strategic leadership, cross-functional collaboration, and technical expertise to drive validation excellence across multiple production areas and projects. Duties/Responsibilities: Lead the development, execution, and lifecycle management of validation programs (VMPs, VPPs, SOPs) for sterile and non-sterile operations. Responsible for directing and mentoring validation staff across multiple production areas to ensure the proper and continuous function of the operations team and adherence to the established procedures and schedulesin alignment with corporate quality and operational goals. Assess process validation capabilities within the Operations organization and propose strategies for improvements to help achieve both short-term and long-term corporate objectives. Direct personnel to the author, complete, and review all associated validation protocols (IQ, OQ, PQs). Write, review, and approve change control orders and CAPAs, validation deviations, investigations, Quality Management System (QMS) oversight, audit, inspection follow-up (CAPA), and support readiness activities for validation. Collaborate with senior validation leadership, outline validation strategy for new processes/equipment, and translate those required to appropriate validation protocols and standard operating procedures. Oversee, assign, and manage all aseptic validation activities and equipment (e.g., lyophilizers, isolators, autoclaves, filling lines), clean utilities (WFI, PW, HVAC), and critical systems Accountable for maintaining the Master Validation Plan of aseptic and non-aseptic processing. Provide strategic direction to process validation strategies, serve as the Subject Matter Expert (SME) to support inspections/audits by third parties (e.g., regulatory agencies), and the timely closure of observations/audit terms. Interface with Regulatory agencies, as required, in conjunction with facility inspections and technical interchanges to represent the company's position concerning validation. Mentor and develop staff regarding teamwork, validation techniques, and procedures to ensure cGMP compliance and other duties, as assigned or as business needs require. Provide direction and serve as project and resource management for the validation teams. Provide oversight and strategic direction for the Computer System Validation (CSV) program and supervise CSV associates. Ensure compliance with cGMP, FDA, EMA (Annex 1), and other global regulatory requirements for validation and qualification. Collaborate with Engineering, Quality Assurance, Manufacturing, and Client to ensure validation strategies support product lifecycle and regulatory submissions. Manage risk-based validation approaches and implement continuous improvement initiatives. Provide strategic input on new facility and equipment design to ensure validation readiness. Lead validation readiness for tech transfers, new product introductions, and capital projects. Ensure robust training and development programs for validation staff. Oversee the aseptic process simulation (APS) program to ensure compliance and readiness for regulatory inspections. Other assigned responsibilities, as needed. Required Skills/Abilities: Ability to read, write, and speak English fluently. Deep understanding of aseptic processing, cleanroom classifications, and contamination control principles. Demonstrated leadership in managing cross-functional teams and complex projects. Proficiency in validation lifecycle documentation and electronic systems (e.g., QMS, VMS, LIMS). Proficient in the operation of manufacturing equipment and processes; knows and complies with Safety Data Sheets and SOP requirements and trained in cGMP's. Mechanically inclined; reads and interprets equipment and process documents; follow operating instructions; and has good computer skills. Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality. Consistently checks all documents for errors and constantly strives for right the first-time mentality. Observes safety and security procedures; responsible for meeting department safety objectives and developing ongoing safe operating procedures consistent with the job requirements. Advanced understanding of applicable regulatory requirements (FDA, EMA, WHO, ICH, international regulatory). Audit experience is strongly preferred. Advanced understanding of industry standards for commissioning and validation of facilities, utilities, and process equipment for cGMP manufacturing. Demonstrate SME-level knowledge of process/equipment validation, computer systems, standards, and GxP regulations. Expertise in validation of sterile manufacturing equipment and processes. Strong technical experience in the successful management of complex validation is required. Able to effectively lead and coordinate complex requests/projects and allocate resources across multiple sites, managing local and remote-based staff. Strong oral and written (reports) communication, organization, and leadership skills. Education and Experience: Bachelor's degree in Science or Engineering, Master's degree preferred Minimum 15 years of progressive leadership of operational validation experience in the Pharmaceutical or Biotechnology industry, with at least 5 years in sterile/aseptic operations. Sound industry knowledge of pharmaceutical and medical device facilities, lyophilization technology, cleanrooms, facilities clean utilities. WFI, purified water, process gasses, HVAC, and industrial processes and utilities. Experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff. Proven track record of leading validation programs in a regulated environment. Experience with regulatory inspections and successful remediation of validation-related findings. Strong experience with project and people management, particularly for large validation projects or programs. Experience in Facility, Equipment, and Utility or Cleaning validation is a must. Experience with Process Validation as a plus.
Operations Director - supporting cloud and AI data center infrastructure customers. Based onsite at our new Salisbury, NC location. We are offering relocation assistance! Please note: This role will require extensive travel to another Jabil site during the first 3-6 months for training, team integration, and operational alignment. The Operations Director is responsible for leading and optimizing all aspects of factory operations, ensuring efficiency, cost-effectiveness, and exceptional customer satisfaction. This role drives operational excellence, strategic planning, and continuous improvement initiatives to enhance productivity and profitability. This role requires a results-driven leader who can balance strategic vision with hands-on execution to drive operational success. What can you expect to do? Leadership & Strategy: Oversee factory operations, including electrical/mechanical assembly, testing, purchasing, planning, production, and inventory control. Align daily operations with company objectives and customer expectations. Operational Excellence: Develop and implement strategies that enhance efficiency, reduce costs, and drive revenue growth while maintaining high-quality standards. Team Management: Lead and develop a high-performing team, ensuring cross-functional collaboration, performance monitoring, and continuous improvement. Customer Engagement: Act as a key liaison with customers to enhance output, yield, and satisfaction through proactive communication and problem-solving. Process Improvement: Drive change management initiatives, implementing continuous productivity and cost-reduction programs. Identify opportunities for resource optimization and operational efficiency. Financial Oversight: Set policies, forecast revenue and capital expenditures, and manage budgets to ensure financial health and sustainability. Compliance & Quality: Ensure all operations comply with industry regulations, company policies, and quality standards. What is the experience needed to be successful in this role? Extensive experience in factory operations, in manufacturing, assembly, or industrial environments. Experience leading end-to-end greenfield and brownfield manufacturing facility startups, including infrastructure development, equipment commissioning, staffing, and operational ramp-up to full production capacity, preferred. Strong financial and analytical skills with the ability to optimize operational costs and business performance. Proven track record in change management, process improvement, and driving efficiency initiatives. Excellent leadership and communication skills, with the ability to influence and collaborate across teams. Proficiency in Microsoft Office (Excel, Word, PowerPoint) and business analytics tools. Education & Experience Requirements Bachelor's degree required, Master's degree preferred. Minimum of 15 years of progressive experience in operations, with a strong track record of leadership, process optimization, and strategic execution in manufacturing or industrial environments. Minimum of four (4) years of experience in high-technology manufacturing services: electronics, data center, server/rack production, semiconductors, or similar industry. Experience with new product introductions required. Minimum of four (4) years of personnel management and team development experience. Extensive experience working directly with customers and managing customer relationships. Benefits Package with Jabil Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes: Competitive Base Salary Annual Bonus Long Term Incentives Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options 401K Match Employee Stock Purchase Plan Paid Time Off Tuition Reimbursement Life, AD&D, and Disability Insurance Commuter Benefits Employee Assistance Program Pet Insurance Adoption Assistance Community Volunteer Opportunities
12/15/2025
Full time
Operations Director - supporting cloud and AI data center infrastructure customers. Based onsite at our new Salisbury, NC location. We are offering relocation assistance! Please note: This role will require extensive travel to another Jabil site during the first 3-6 months for training, team integration, and operational alignment. The Operations Director is responsible for leading and optimizing all aspects of factory operations, ensuring efficiency, cost-effectiveness, and exceptional customer satisfaction. This role drives operational excellence, strategic planning, and continuous improvement initiatives to enhance productivity and profitability. This role requires a results-driven leader who can balance strategic vision with hands-on execution to drive operational success. What can you expect to do? Leadership & Strategy: Oversee factory operations, including electrical/mechanical assembly, testing, purchasing, planning, production, and inventory control. Align daily operations with company objectives and customer expectations. Operational Excellence: Develop and implement strategies that enhance efficiency, reduce costs, and drive revenue growth while maintaining high-quality standards. Team Management: Lead and develop a high-performing team, ensuring cross-functional collaboration, performance monitoring, and continuous improvement. Customer Engagement: Act as a key liaison with customers to enhance output, yield, and satisfaction through proactive communication and problem-solving. Process Improvement: Drive change management initiatives, implementing continuous productivity and cost-reduction programs. Identify opportunities for resource optimization and operational efficiency. Financial Oversight: Set policies, forecast revenue and capital expenditures, and manage budgets to ensure financial health and sustainability. Compliance & Quality: Ensure all operations comply with industry regulations, company policies, and quality standards. What is the experience needed to be successful in this role? Extensive experience in factory operations, in manufacturing, assembly, or industrial environments. Experience leading end-to-end greenfield and brownfield manufacturing facility startups, including infrastructure development, equipment commissioning, staffing, and operational ramp-up to full production capacity, preferred. Strong financial and analytical skills with the ability to optimize operational costs and business performance. Proven track record in change management, process improvement, and driving efficiency initiatives. Excellent leadership and communication skills, with the ability to influence and collaborate across teams. Proficiency in Microsoft Office (Excel, Word, PowerPoint) and business analytics tools. Education & Experience Requirements Bachelor's degree required, Master's degree preferred. Minimum of 15 years of progressive experience in operations, with a strong track record of leadership, process optimization, and strategic execution in manufacturing or industrial environments. Minimum of four (4) years of experience in high-technology manufacturing services: electronics, data center, server/rack production, semiconductors, or similar industry. Experience with new product introductions required. Minimum of four (4) years of personnel management and team development experience. Extensive experience working directly with customers and managing customer relationships. Benefits Package with Jabil Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes: Competitive Base Salary Annual Bonus Long Term Incentives Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options 401K Match Employee Stock Purchase Plan Paid Time Off Tuition Reimbursement Life, AD&D, and Disability Insurance Commuter Benefits Employee Assistance Program Pet Insurance Adoption Assistance Community Volunteer Opportunities